FDA 510(k)

Q-Switched Nd: YAG Laser Systems

N.º K: K260256 · 2026-05-04

SolicitanteShanghai Apolo Medical Technology Co., Ltd.

Fecha de decisión2026-05-04

Código de productoGEX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Q-Switched Nd: YAG Laser Systems is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Apolo Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-05-04 under 510(k) number K260256. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Q-Switched Nd: YAG Laser Systems?

Q-Switched Nd: YAG Laser Systems is a medical device that received FDA 510(k) clearance on 2026-05-04. The listed applicant is Shanghai Apolo Medical Technology Co., Ltd.. The 510(k) number is K260256.

When did Q-Switched Nd: YAG Laser Systems receive FDA 510(k) clearance?

Q-Switched Nd: YAG Laser Systems received FDA 510(k) clearance on 2026-05-04, under 510(k) number K260256.

Who is the listed applicant for Q-Switched Nd: YAG Laser Systems?

The FDA 510(k) record lists Shanghai Apolo Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Q-Switched Nd: YAG Laser Systems?

The FDA product code for Q-Switched Nd: YAG Laser Systems is GEX. This falls under the Gastroenterology category.

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Fuente oficial

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